NCT00630786

Conatumumab/Panitumumab Combination Metastatic Colorectal Cancer Study

A Phase 1b/2 Trial of AMG 655 in Combination With Panitumumab in Subjects With Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an exploratory phase 1b/2, global, multicenter, single-arm, 2-part (phase 1b and 2) study of conatumumab in combination with panitumumab in patients with Metastatic Colorectal Cancer.

Detailed description

This is an exploratory phase 1b/2, global, multicenter, single-arm, 2-part (phase 1b and 2) study of conatumumab in combination with panitumumab in patients with Metastatic Colorectal Cancer. The objective for Part 1 is to identify a tolerable dose of conatumumab in combination with panitumumab based on the incidence of dose-limiting toxicities in patients with Metastatic Colorectal Cancer. The objective for Part 2 is to evaluate the objective response rate stratified by Kirsten Rat Sarcoma Virus Oncogene (KRAS) status (wild-type versus mutant) in patients with Metastatic Colorectal Cancer treated with the combination of panitumumab and conatumumab (tolerable dose identified in part 1).

Conditions

• Colon Cancer
• Colorectal Cancer
• Rectal Cancer
• Metastatic Colorectal Cancer
• Oncology

Interventions

Type	Name	Description
DRUG	Panitumumab	Administered by intravenous infusion
DRUG	Conatumumab	Administered by intravenous infusion

Timeline

• Start date: 2008-01-01
• Primary completion: 2009-05-01
• Completion: 2010-11-01
• First posted: 2008-03-07
• Last updated: 2014-02-06
• Results posted: 2014-02-06